Navamedic ASA: Enters into partnership agreement with Orexigen Therapeutics for Nordic launch of Mysimba®
(Thomson Reuters ONE) -
Oslo, May 2, 2017 - Navamedic ASA (OSE: NAVA), the Norwegian medtech and
pharmaceutical products company, today announced it has entered into a five-year
agreement with Orexigen Therapeutics Ireland, Ltd., the subsidiary of the
American biopharmaceutical company Orexigen Therapeutics, Inc. (Nasdaq: OREX),
for Nordic marketing and distribution of Mysimba®, a prescription
pharmaceutical.
"We are very pleased to announce the agreement with Orexigen Therapeutics for
distribution of the prescription anti-obesity pharmacutical Mysimba (naltrexone
HCl/bupropion HCl prolonged release), in the Nordic countries, and to offer
Nordic physicians a prescription alternative for treating obesity. Adult obesity
is a significant public health challenge and a major risk factor for a number of
chronic diseases. Mysimba is used in combination with a reduced-calorie diet and
increased physical activity for patients who are overweight or struggling with
obesity in the presence of one or more weight-related co-morbidities (e.g. type
2 diabetes, dyslipidaemia, or controlled hypertension). The treatment targets a
significant unmet need within the Nordic market where 15-20 percent of the
population are overweight or struggling with obesity. The product strengthens
our pharmaceutical products portfolio, and we believe the partnership agreement
with Orexigen opens up a significant market opportunity and revenue potential
moving forward," says Tom Rönnlund, Chief Executive Officer of Navamedic.
Mysimba® is a centrally acting anti-obesity product used in adjunct to diet and
exercise for management of weight in obese (BMI of >=30 kg/m2) and overweight
(BMI >=27 kg/m2) adults with weight-related complications, such as diabetes,
abnormally high levels of fat in the blood, or high blood pressure. The product
has a unique, dual-action mechanism, using naltrexone and bupropion, which act
on two separate areas of the brain, the hunger center and the reward system, to
reduce hunger and help control cravings
The medication is approved by the European Union / European Medicines Agency,
and under the agreement, Navamedic will have exclusive distribution rights in
the Nordic region. Navamedic expects to begin marketing the product during Q4
2017 for an initial period of five years, renewable for an additional five-year
period, according to the terms of the Agreement. Orexigen will supply Mysimba
tablets to Navamedic for a negotiated transfer price and upfront milestone
payments at signing and first commercialization sales. Additional milestone
payments will be based on future sales levels.
"The agreement is a compelling opportunity for Navamedic to expand its portfolio
with an exciting brand within an area of medicine with significant potential. It
is also in line with the stated strategy to continue to form solid partnerships
and have inflow of new products," says Rönnlund.
Navamedic will market Mysimba® as part of the diversified pharmaceutical and
healthcare products portfolio under the terms of the distributor partnership
signed in April 2017.
For further information, please contact:
Tom Rönnlund, CEO, Navamedic ASA
Telephone: +46 727 320 321
ABOUT NAVAMEDIC:
Navamedic ASA is a Norwegian medtech and pharmaceutical products company,
delivering products to patients, hospitals and pharmacies in the Nordic and
Benelux markets. The Group's Medtech business has developed and is currently
introducing the next generation of digital urine meter Sippi®. Navamedic's
Pharma and Healthcare business is a distributor of products supplied by a number
of pharmaceutical manufacturers. Navamedic is listed on the Oslo Stock Exchange
(ticker: NAVA).
ABOUT MYSIMBA®
Mysimba is approved in the European Union for use as an adjunct to a reduced-
calorie diet and increased physical activity for chronic weight management in
adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese), or
27 kg/m2 or greater (overweight) in the presence of at least one weight-related
comorbid condition (e.g., hypertension, type 2 diabetes mellitus or
dyslipidemia). In the United States, the drug is approved as Contrave®
(naltrexone HCl / bupropion HCl extended release).
The exact neurochemical effects of Mysimba / Contrave leading to weight loss are
not fully understood. Mysimba / Contrave has two components: naltrexone, an
opioid antagonist, and bupropion, a relatively weak inhibitor of the neuronal
reuptake of dopamine and norepinephrine. Nonclinical studies suggest that
naltrexone and bupropion have effects on two separate areas of the brain
involved in the regulation of food intake: the hypothalamus (appetite regulatory
center) and the mesolimbic dopamine circuit (reward system).
Four 56-week multicenter, double-blind, placebo-controlled Phase 3 clinical
trials were conducted to evaluate the effect of Mysimba / Contrave in
conjunction with lifestyle modification in 4,536 subjects randomized to Mysimba
/ Contrave or placebo. In these studies, the most common adverse reactions (>5
percent) seen in patients taking Mysimba / Contrave included nausea,
constipation, headache, vomiting, dizziness, insomnia, dry mouth, and diarrhea.
The clinical trial program also included a double-blind, placebo-controlled
cardiovascular outcomes trial known as the Light Study. The primary objective of
this study was to evaluate the occurrence of major adverse cardiovascular events
(MACE) in overweight and obese adults with cardiovascular risk factors receiving
Contrave. A second study, designed to address post-approval requirements in both
Europe and the United States, is planned in order to further evaluate
cardiovascular outcomes.
ABOUT OREXIGEN THERAPEUTICS
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the
treatment of obesity. Orexigen's first product, Contrave® (naltrexone HCl and
bupropion HCl extended release), was approved in the United States in September
2014. In the European Union, the drug has been approved under the brand name
Mysimba® (naltrexone HCl/ bupropion HCl prolonged release). Orexigen is
undertaking a range of development and commercialization activities, both on its
own and with strategic partners, to bring Contrave / Mysimba to patients around
the world. Further information about Orexigen can be found at www.orexigen.com.
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Navamedic ASA via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 02.05.2017 - 09:00 Uhr
Sprache: Deutsch
News-ID 539560
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contact information:
Town:
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Kategorie:
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